The audit of the company’s API manufacturing plant at Middleburg, New York has been completed by US FDA
Dr Reddy’s Laboratories said the US health regulator has issued a Form 483 with three observations after inspecting its manufacturing facility in Middleburg, New York. The audit of the company’s active pharmaceutical ingredients (API) manufacturing plant at Middleburg, New York has been completed by the US Food and Drug Administration (US FDA), the Hyderabad-based drug major said in a regulatory filing.
“We have been issued a Form 483 with 3 (three) observations. We will address them comprehensively within the stipulated timeline. Currently, we do not have any sales from this plant,” it added.
As per the US FDA, Form 483 is issued to firm management after an inspection when investigators have observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related acts.
PTI
